Monthly Archives: July 2018

July 31, 2018 – The Fair Pricing Coalition (FPC) today commended Gilead Sciences for recent improvements to its Advancing Access program for Truvada (tenofovir disoproxil fumarate/emtrictabine) as pre-exposure prophylaxis (PrEP). In a July 24, 2018, letter to advocates, Gilead announced that its copay assistance maximum would be increased from $4,800 to $7,200 a year. This change goes into effect September 1. Additionally, beginning July 1, people vulnerable to HIV who qualify for the Advancing Access Medication Assistance Program (MAP) – which provides free drug to uninsured or underinsured individuals who meet annual income criteria – will remain eligible for 12 months instead of six months.

“For at least two years, the FPC – independently and as part of a coalition of community leaders concerned about Truvada pricing and access – have been pushing Gilead to make these long-overdue changes,” said Tim Horn, Chair of ad hoc coalition of HIV and hepatitis C virus activists. “We have documented cases where individuals with health insurance acquired HIV because they could no longer afford the out-of-pocket costs associated with taking Truvada after meeting the current copay assistance maximum allowance. And we’re pleased that people in need of free Truvada for PrEP through the MAP can count on access for 12 months, as opposed to having to reapply every six months.”

Despite the FPC’s repeated requests going back to the time of the launch of Truvada for PrEP, which would have allowed for a more detailed look at the financial need of those seeking the medication, Gilead refused to make public the methodology by which it arrived at its support levels. This forced the FPC and its colleagues in the community to gather information independently to document the support programs’ shortfalls and their consequences.

In a related matter, the Gilead announcement does not address the lingering concern expressed by advocates about the application of co-pay accumulators by commercial health insurance plans. In short, these co-pay accumulators may prevent copay assistance from being applied toward members’ deductible requirements, which can be very high, particularly for those on Bronze or Silver Affordable Care Act Marketplace plans with lower premiums.

“Copay accumulators are unacceptable barriers to essential medications,” said John Peller of the FPC. “They are a crude tactic by commercial insurers to deal with runaway prescription drug prices. While we appreciate that they are meant to drive patients to use cheaper generic drugs, there is no evidence-based generic alternative to Truvada for PrEP. People vulnerable to HIV are being caught in the middle of a war between insurance companies and drug manufacturers. We need a truce, which must begin with manufacturers – including Gilead – offering the discounts and rebates necessary for insurers to do away with this unfair and dangerous practice.”

Separately, Gilead has also announced that patient representatives from health care facilities can sign Advancing Access assistance program applications from adolescents that need PrEP. The FDA approved PrEP for adolescents earlier in 2018.

“We are glad to see Gilead recognize that not all youth will be able to get a parent or guardian’s signature to access programs that make PrEP affordable,” said Horn. “Homophobia and transphobia remain pervasive threats to sexual health in the U.S., particularly among queer youth. This program change should help improve access to Truvada for PrEP among vulnerable adolescents. The need for awareness of this access mechanism is critical and we encourage Gilead to do everything possible to inform health care providers, community leaders, and adolescents in need.”

According to figures released at the recent International Conference on AIDS held in Amsterdam, as of 2016 only about 7 percent of the 1.1 million people most at risk of acquiring HIV in the United States are accessing Truvada for PrEP. Among African American and Latino/a gay, bisexual and other men who have sex with men and transgender and cisgender women of color, PrEP uptake has been even less robust.

“The FPC has discussed many times with Gilead the multiple barriers to PrEP uptake, with the ever-escalating cost of Truvada not the least of those factors,” said Horn. “In this case, we are pleased with the expansion of support for those who need PrEP, all the while dismayed that such programs are even necessary.”

First PI-based single-tablet regimen debuts in the United States at record-high price.

July 23, 2018 – The Fair Pricing Coalition (FPC), an ad hoc coalition of HIV and hepatitis C virus (HCV) activists, today expressed its strong dissatisfaction with Janssen Therapeutics over its launch price for Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide). At a wholesale acquisition cost (WAC) of $41,784 a year, Janssen has set a record-high price for single-tablet antiretroviral regimens (STRs), ignoring the need for cost containment in HIV care and defying a groundswell of public and governmental demands for lower prescription drug prices.

“Symtuza is a useful addition to the HIV treatment toolbox for people living with HIV requiring a protease inhibitor and single-tablet dosing,” said FPC Chair Tim Horn. “However, the unprecedented price is very difficult to swallow. Symtuza is roughly $4,700 to $6,400 more than the current WAC prices for Stribild, Genvoya, and Biktarvy, until now the most expensive STRs on the market. We understand that Janssen isn’t charging any more than the components included in Symtuza, specifically Prezista (darunavir), Tybost (cobicistat), and Descovy (emtricitabine/tenofovir alafenamide), but the original development costs of these components have already been recovered many times over. Janssen missed the opportunity to introduce both an easier-to-take and less costly version of antiretrovirals that have all been available for some time now, which is unfortunate.”

When in doubt about STR research and development investments, FPC does advocate for parity pricing with the individual components – but with a very important stipulation. “We urge companies to factor out the egregious annual price increases taken on the components over the years and focus instead on what the component prices should be, based on either standard or medical inflation rates,” said FPC member Paul Arons. “We’re being punished twice – by price increases on older drugs that have snowballed compared to actual inflation rates, and on new drug products with prices based on these bloated benchmarks.”

Had prices of Symtuza’s component drugs risen only 28.8%, in line with the medical inflation rate over the years during which most of them were launched, the maximum price should have been $30,394 – $12,390 less than Janssen’s WAC. And with overall U.S. inflation, the WAC could reasonably have been 16.6% higher, or as low as $27,508. Having shared such calculations with Janssen, the Fair Pricing Coalition considers the company’s pricing decision especially regrettable.

The Symtuza launch price is particularly problematic in the context of comparable generic and quasi-generic drugs becoming widely available in the U.S. For example, the darunavir in Symtuza is one of two protease inhibitors (the other being atazanavir, which is now available as a stand-alone generic) classified as components of “Recommended Initial Regimens in Certain Clinical Situations” in the Department of Health and Human Services’ Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV, meaning they are not among the primary initial regimens. That means Symtuza is likely to have a more limited market than a drug that is listed in the guidelines for more widespread use. Common sense would dictate that Janssen would assign a lower price to a drug like Symtuza that is less clinically important.

Other components of Symtuza have generic or quasi-generic equivalents. “Using current and anticipated generic drug prices as a benchmark, a minimal fair price for Symtuza should have been below $10,000 annually,” said Horn. “Symtuza’s launch price goes to show that fairness rules aren’t being applied to newer HIV drug products with marginal advantages over older offerings, which is, at best, a shame, and at worst, a genuine threat to our stretched-thin systems of HIV care coverage.”

“We take some solace at the news Janssen has increased its copay assistance limit to $10,500,” said FPC member John Peller. However, the maximum eligibility for full indigent coverage under the Johnson & Johnson Patient Assistance Foundation remains at only 300% of the Federal Poverty Level – 40% short of the current pharmaceutical standard. Thus, the cost of Symtuza for a person living with HIV who earns just above that level could be as much as a full year’s income. “To what extent Janssen’s financial support programs defray out-of-pocket costs, particularly for such high-priced HIV drug products in an era of copay accumulators and an upswing in public and private policy attacks on products intended to defray patient costs, remains to be seen,” Peller added.